5-Pk, external hygienic, CO2RE Intima KT76685

GUDID 00817495024400

5-Pk, external hygienic, CO2RE Intima

Candela Corporation

Dermatological carbon dioxide laser system

• Primary Device ID: 00817495024400
• NIH Device Record Key: a1fe4bc5-4385-46e4-ad92-12c210db6a7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5-Pk, external hygienic, CO2RE Intima
• Version Model Number: KT76685
• Catalog Number: KT76685
• Company DUNS: 053468385
• Company Name: Candela Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495024400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181523

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-30
• Device Publish Date: 2023-10-20

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